AutismNCT05406076
the Efficacy of Oral Motor Therapy in Children With Autism
A study testing oral motor therapy and ABA in people with Autism, run by The First Affiliated Hospital of Anhui Medical University.
Trial summary
Children with Autism spectrum disorders have speech disorders, which in turn aggravate communication difficulties and lead to an increase in their core symptoms. This experiment attempts to investigate the efficacy of Chinese language oral motor therapy in improving various aspects of articulation, language ability… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- oral motor therapy and ABA
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who meet the DSM-V diagnosis of autism.
- Age 2-5 years old, regardless of gender.
- Native Chinese language.
- No prior oral motor therapy.
- Family members voluntarily participated in this study and signed an informed consent form.
Who cannot join
- Children with co-occurring epilepsy.
- Children with comorbid other psychiatric disorders.
- Children with severe hearing impairment, history of visual impairment/blindness, organic disease of the mouth/throat, or significant medical illness or condition that prevents the child from participating in treatment procedures.
- Children who received other oral motor training or speech articulation therapy during the intervention period.
- Those who could not perform the intervention as planned after participating in the experiment.
- Those deemed unsuitable by the investigator to participate in this experiment.
About this study
Official title: A Multicenter Randomized Controlled Study of the Efficacy of Oral Motor Therapy in Children With Autism
Children with Autism spectrum disorders have speech disorders, which in turn aggravate communication difficulties and lead to an increase in their core symptoms. This experiment attempts to investigate the efficacy of Chinese language oral motor therapy in improving various aspects of articulation, language ability, and behavior of children with autism in conjunction with the International General Autism Scale, and provides a basis for the rational formulation of clinical treatment plans.
Read the detailed description
Oral Motor Therapy (OMT) is a treatment process that uses tactile and proprioceptive stimulation techniques to promote the normalization of the sensory perception of the mouth (jaw, lips, tongue), suppress abnormal mouth movement patterns, and establish normal mouth movement patterns, following the principles of motor skill development.
This study investigates the efficacy of Chinese language oral motor therapy on improving various aspects of articulation, language ability, and behavior of children with autism. The study is divided into two parts, each eight weeks long. Eighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups: the experimental group and the control group, in a 1:1 ratio. The experimental group was treated with 2 months of ABA+oral motor therapy followed by 2 months of ABA therapy; the control group was treated with 2 months of ABA therapy followed by 2 months of ABA+oral motor therapy.
Each subject underwent ABC, CARS, S-S, VB-MAPP, and ABLLS-R assessments before enrollment, 2 months after enrollment, and after discharge from the group.
- Conditions
- Autism
- Being tested
- oral motor therapy, ABA
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral motor therapyBehavioural
Rigorous Chinese language oral motor therapy, including treatment of oral perceptual disorders and treatment of oral motor disorders. The treatment follows three basic principles: a combination of basic training and specific treatment; a combination of self-help and assisted treatment; and a combination of exercises, cues, and stimulation techniques. 30-40 min/session, 1 session/day, 5 sessions/week.
ABABehavioural
The mainstream ASD intervention approach with evidence-based support is currently recognized worldwide. Treatment follows the operational core principles of ABA, which are to establish learning goals based on the child's ability level, design teaching situations and select reinforcers for them, change the child's behavior problems with operational constraints, and to eliminate or improve problem behaviors through appropriate interventions to shape new adaptive behaviors. The training time is at least 20 hours per week.
| Study group | Role | What they receive |
|---|---|---|
| Oral Motor Therapy/ABA | Active comparator | Eighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups according to a 1:1 ratio. The experimental group was first treated with 2 months of ABA + oral motor therapy, followed by 2 months of ABA treatment.
Oral motor therapy appliances can be used during mouth muscle training sessions, depending on the individual needs of the child. 30-40 min/session, 1 session/day, 5 sessions/week.
ABA training time is at least 20 hours per week. The therapist is fully aware of each stage of the child's training during the teaching process and can make an accurate assessment of the child. Receives: Behavioral: oral motor therapy; Behavioral: ABA |
| ABA/Oral Motor Therapy | Active comparator | Eighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups according to a 1:1 ratio. The control group was treated with 2 months of ABA followed by 2 months of ABA + oral motor therapy.
Oral motor therapy appliances can be used during mouth muscle training sessions, depending on the individual needs of the child. 30-40 min/session, 1 session/day, 5 sessions/week.
ABA training time is at least 20 hours per week. The therapist is fully aware of each stage of the child's training during the teaching process and can make an accurate assessment of the child. Receives: Behavioral: oral motor therapy; Behavioral: ABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) scores
VB-MAPP is a criterion-referenced language and academic proficiency assessment system, curriculum instruction and skill tracking system for children with autism and speech and language delays. It is used for children 0-48 months of age. It has five components: milestone assessment, impairment assessment, transition assessment, task analysis, and supportive competencies and goals for placement and individualized education program (IEP).
Measured: Baseline (week 0), Week 8，Week 16
Changes in Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) scores
The ABLLS-R is for children ages 0-12. The scale has 25 major assessment items and 544 skill subtests that help children with autism learn the skills they need to communicate effectively and daily; and it can track the learning of each skill, which means that multiple assessments can be made, with the later assessment building on the previous one, giving this autism assessment tool a curriculum guide role.
Measured: Baseline (week 0), Week 8，Week 16
Change in the Autism Behavior Scale (ABC) scores
The ABC scale is widely used in the assessment of autism conditions and the evaluation of treatment outcomes, and is one of the most commonly used autism assessment scales. It is used for screening of autistic individuals aged 18 months to 35 years. The scale is assessed by the child's parents or someone with whom the child has lived for at least 2 weeks and takes approximately 10-15 minutes to assess.
Measured: Baseline (week 0), Week 8，Week 16
Change in Childhood Autism Rating Scale (CARS) scores
CARS is an observation tool used by clinicians for speech, behavior, and sensory perception in children with autism.
Measured: Baseline (week 0), Week 8，Week 16
Change in China Rehabilitation Research Center version of the Sign-Significance（S-S，CRRC version） scores
The S-S detects the gap between the level of language delay and the actual age, as well as the status of the language delay, and is suitable for children aged 1-6.5 years with language delay. The test is administered individually and takes approximately 40 minutes to complete.
Measured: Baseline (week 0), Week 8，Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Hefei Kanghua Rehabilitation Hospital, Hefei Jingu Rehabilitation Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406076
- Sponsor's protocol ID
- WDX-05
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study of the Efficacy of Oral Motor Therapy in Children With Autism
- ClinicalTrials.gov ID
- NCT05406076
- Acronym / sponsor ID
- WDX-05
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Hefei Kanghua Rehabilitation Hospital, Hefei Jingu Rehabilitation Hospital
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with Autism spectrum disorders have speech disorders, which in turn aggravate communication difficulties and lead to an increase in their core symptoms. This experiment attempts to investigate the efficacy of Chinese language oral motor therapy in improving various aspects of articulation, language ability, and behavior of children with autism in conjunction with the International General Autism Scale, and provides a basis for the rational formulation of clinical treatment plans.
Detailed description
Oral Motor Therapy (OMT) is a treatment process that uses tactile and proprioceptive stimulation techniques to promote the normalization of the sensory perception of the mouth (jaw, lips, tongue), suppress abnormal mouth movement patterns, and establish normal mouth movement patterns, following the principles of motor skill development.
This study investigates the efficacy of Chinese language oral motor therapy on improving various aspects of articulation, language ability, and behavior of children with autism. The study is divided into two parts, each eight weeks long. Eighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups: the experimental group and the control group, in a 1:1 ratio. The experimental group was treated with 2 months of ABA+oral motor therapy followed by 2 months of ABA therapy; the control group was treated with 2 months of ABA therapy followed by 2 months of ABA+oral motor therapy.
Each subject underwent ABC, CARS, S-S, VB-MAPP, and ABLLS-R assessments before enrollment, 2 months after enrollment, and after discharge from the group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Motor Therapy/ABA | Active comparator | Behavioral: oral motor therapy, Behavioral: ABAEighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups according to a 1:1 ratio. The experimental group was first treated with 2 months of ABA + oral motor therapy, followed by 2 months of ABA treatment. Oral motor therapy appliances can be used during mouth muscle training sessions, depending on the individual needs of the child. 30-40 min/session, 1 session/day, 5 sessions/week. ABA training time is at least 20 hours per week. The therapist is fully aware of each stage of the child's training during the teaching process and can make an accurate assessment of the child. |
| ABA/Oral Motor Therapy | Active comparator | Behavioral: oral motor therapy, Behavioral: ABAEighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups according to a 1:1 ratio. The control group was treated with 2 months of ABA followed by 2 months of ABA + oral motor therapy. Oral motor therapy appliances can be used during mouth muscle training sessions, depending on the individual needs of the child. 30-40 min/session, 1 session/day, 5 sessions/week. ABA training time is at least 20 hours per week. The therapist is fully aware of each stage of the child's training during the teaching process and can make an accurate assessment of the child. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children who meet the DSM-V diagnosis of autism.
- Age 2-5 years old, regardless of gender.
- Native Chinese language.
- No prior oral motor therapy.
- Family members voluntarily participated in this study and signed an informed consent form.
Key exclusion criteria (6 listed)
- Children with co-occurring epilepsy.
- Children with comorbid other psychiatric disorders.
- Children with severe hearing impairment, history of visual impairment/blindness, organic disease of the mouth/throat, or significant medical illness or condition that prevents the child from participating in treatment procedures.
- Children who received other oral motor training or speech articulation therapy during the intervention period.
- Those who could not perform the intervention as planned after participating in the experiment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral motor therapyRigorous Chinese language oral motor therapy, including treatment of oral perceptual disorders and treatment of oral motor disorders. The treatment follows three basic principles: a combination of basic training and specific treatment; a combination of self-help and assisted treatment; and a combination of exercises, cues, and stimulation techniques. 30-40 min/session, 1 session/day, 5 sessions/week. | Behavioural | ABA/Oral Motor Therapy, Oral Motor Therapy/ABA |
| ABAThe mainstream ASD intervention approach with evidence-based support is currently recognized worldwide. Treatment follows the operational core principles of ABA, which are to establish learning goals based on the child's ability level, design teaching situations and select reinforcers for them, change the child's behavior problems with operational constraints, and to eliminate or improve problem behaviors through appropriate interventions to shape new adaptive behaviors. The training time is at least 20 hours per week. | Behavioural | ABA/Oral Motor Therapy, Oral Motor Therapy/ABA |
Primary outcome
Changes in the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) scores
Time frame: Baseline (week 0), Week 8，Week 16
VB-MAPP is a criterion-referenced language and academic proficiency assessment system, curriculum instruction and skill tracking system for children with autism and speech and language delays. It is used for children 0-48 months of age. It has five components: milestone assessment, impairment assessment, transition assessment, task analysis, and supportive competencies and goals for placement and individualized education program (IEP).
Changes in Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) scores
Time frame: Baseline (week 0), Week 8，Week 16
The ABLLS-R is for children ages 0-12. The scale has 25 major assessment items and 544 skill subtests that help children with autism learn the skills they need to communicate effectively and daily; and it can track the learning of each skill, which means that multiple assessments can be made, with the later assessment building on the previous one, giving this autism assessment tool a curriculum guide role.
Change in the Autism Behavior Scale (ABC) scores
Time frame: Baseline (week 0), Week 8，Week 16
The ABC scale is widely used in the assessment of autism conditions and the evaluation of treatment outcomes, and is one of the most commonly used autism assessment scales. It is used for screening of autistic individuals aged 18 months to 35 years. The scale is assessed by the child's parents or someone with whom the child has lived for at least 2 weeks and takes approximately 10-15 minutes to assess.
Change in Childhood Autism Rating Scale (CARS) scores
Time frame: Baseline (week 0), Week 8，Week 16
CARS is an observation tool used by clinicians for speech, behavior, and sensory perception in children with autism.
Change in China Rehabilitation Research Center version of the Sign-Significance（S-S，CRRC version） scores
Time frame: Baseline (week 0), Week 8，Week 16
The S-S detects the gap between the level of language delay and the actual age, as well as the status of the language delay, and is suitable for children aged 1-6.5 years with language delay. The test is administered individually and takes approximately 40 minutes to complete.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing oral motor therapy and ABA in people with Autism, run by The First Affiliated Hospital of Anhui Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) scores (time frame: Baseline (week 0), Week 8，Week 16). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.